Evaluating Onyx™ Liquid Embolic System for treating active arterial bleeding

PELE IDE Clinical Study, Peripheral Onyx™ Liquid Embolic Safety and Effectiveness of The Onyx™ LES for Embolization of Arterial Hemorrhage in the Peripheral Vasculature

This study is testing whether the Onyx™ Liquid Embolic System can safely and effectively stop active bleeding in patients with peripheral artery issues.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 119 (estimated)
• Ages: 22 Years and up
• Sex: All
• Sponsor: Medtronic Endovascular (industry)
• Locations: 16 sites (Phoenix, Arizona and 15 other locations)
• Trial ID: NCT06742801 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety and effectiveness of the Onyx™ Liquid Embolic System in patients experiencing active arterial bleeding in the peripheral vasculature, which excludes the heart and brain. It is a pivotal, prospective, multi-center, non-randomized, single-arm study enrolling up to 135 subjects across 25 sites in the United States. Participants will undergo the embolization procedure and will have follow-up visits at hospital discharge and 30 days post-procedure to monitor outcomes and any need for reintervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with confirmed active arterial bleeding in the peripheral vasculature suitable for embolization.

Not a fit: Patients who are pregnant, breastfeeding, or have active infections will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve outcomes for patients with severe peripheral arterial hemorrhage.

How similar studies have performed: Other studies have shown promise with embolization techniques for similar conditions, suggesting a potential for success with this approach.

Eligibility criteria

Inclusion Criteria:

1. Patient is ≥ 22 years old.
2. Active arterial bleeding in the peripheral vasculature confirmed by radiologic and/or endoscopic imaging and deemed suitable for embolization treatment by the investigator.

   In this study, peripheral vasculature is defined as outside the brain and heart.
3. Patient or legally authorized representative (LAR) is able to provide written consent to participate in the study.
4. Life expectancy of \>30 days, in the opinion of the investigator at the time of enrollment.
5. Target treatment area is free from prior embolization treatment.

Exclusion Criteria:

1. Pregnant or breastfeeding.
2. Symptoms of active infection.
3. Patient is known to be participating in the study of an investigational drug, biologic, or device.
4. Contrast allergy or other contraindication to angiography, CT, or catheterization, including contrast sensitivity that cannot be adequately treated prior to index procedure.
5. Known allergy to components of Onyx™.
6. Target vasculature unsuitable for the delivery of Onyx™ based upon physician assessment.
7. More than 4 target lesions will require embolization, in the investigator's opinion after imaging-based assessment.

Where this trial is running

Phoenix, Arizona and 15 other locations

• Mayo Clinic — Phoenix, Arizona, United States (RECRUITING)
• University of California, Irvine — Irvine, California, United States (RECRUITING)
• Stanford Medical Center — Palo Alto, California, United States (RECRUITING)
• UCHealth University of Colorado Hospital — Aurora, Colorado, United States (RECRUITING)
• Yale New Haven — New Haven, Connecticut, United States (RECRUITING)
• University of Chicago — Chicago, Illinois, United States (RECRUITING)
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States (RECRUITING)
• Masschusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
• CHI Health Creighton University Medical Center-Bergan-Mercy — Omaha, Nebraska, United States (RECRUITING)
• Albany Medical Center — Albany, New York, United States (RECRUITING)
• The Mount Sinai — New York, New York, United States (RECRUITING)
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (RECRUITING)
• The Ohio State University — Columbus, Ohio, United States (RECRUITING)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
• Univ Of Texas Southwestern — Dallas, Texas, United States (RECRUITING)
• The University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Osman Ahmed, MD — University of Chicago
• Study coordinator: Janki Shah

Conditions: Peripheral Arterial Hemorrhage, Trauma, GI Bleed, Ulcer, Hemorrhage, Embolization treatment